Methods for stabilizing a bioprosthetic tissue by chemical modification of antigenic carbohydrates
First Claim
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1. A method for improving the performance of a bioprosthetic implant, the method comprising:
- treating a fixed bioprosthetic tissue with an oxidizing agent that selectively oxidizes antigenic carbohydrates having vicinal diols to produce free aldehyde or acid moieties on the antigenic carbohydrate andtreating the bioprosthetic tissue with a capping agent, the capping agent comprising a primary amine or alcohol which combines with the aldehyde or acid to form an imine, amide or ester.
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Abstract
Methods are provided herein for modifying antigenic carbohydrate epitopes within a xenographic bioprosthetic tissue by oxidation of vicinal diols to form aldehydes or acids and subsequence reductive amination of aldehydes to form stable secondary amines, or amidation or esterification of acids to form stable amides or esters. Advantageously, methods provided herein mitigate the antigenicity of the bioprosthetic tissue while leaving the overall tissue structure substantially undisturbed, and thereby enhance the durability, safety and performance of the bioprosthetic implant.
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Citations
48 Claims
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1. A method for improving the performance of a bioprosthetic implant, the method comprising:
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treating a fixed bioprosthetic tissue with an oxidizing agent that selectively oxidizes antigenic carbohydrates having vicinal diols to produce free aldehyde or acid moieties on the antigenic carbohydrate and treating the bioprosthetic tissue with a capping agent, the capping agent comprising a primary amine or alcohol which combines with the aldehyde or acid to form an imine, amide or ester. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30, 31, 32, 33, 34, 35, 36, 37, 38, 39, 40, 41, 42, 43)
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44. A method for improving the performance of a bioprosthetic implant, the method comprising the steps of:
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obtaining the bioprosthetic tissue, wherein the bioprosthetic tissue is a fresh tissue; fixing the bioprosthetic tissue with a fixation agent comprising glutaraldehyde; treating the bioprosthetic tissue with a bioburden reduction solution comprising formaldehyde, ethanol, and a polyethylene sorbital ester solution; treating the bioprosthetic tissue with an oxidizing agent that selectively oxidizes antigenic carbohydrates having vicinal diols to produce free aldehyde or acid moieties on the antigenic carbohydrate; treating the bioprosthetic tissue with a capping agent, wherein the capping agent comprises a primary amine or an alcohol, wherein the primary amine interacts with the aldehyde to form an imine, or an acid to form an amide; and
the alcohol interacts with the acid to form an ester;treating the bioprosthetic tissue with a stabilizing agent, wherein the stabilizing agent interacts with the imine to form a secondary amine and esters to form an amide; drying the bioprosthetic tissue with ethanol and glycerol; and sterilizing the bioprosthetic tissue with ethylene oxide. - View Dependent Claims (45, 46, 47, 48)
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Specification